Experience with a Global Reach
The Specialized CRO for MedTech Innovators
Beaufort was purpose-built for the regulatory, clinical, and operational complexities of medical device trials.
- Device-Specific Expertise – Clinical strategies tailored to your regulatory pathway
- Regulatory Navigation – Deep experience with FDA, EU MDR, and global regulatory requirements for faster approvals
- Adaptive Approach – Flexible solutions that evolve with the development of your device
- Timeline Acceleration – Strategies to overcome clinical trial bottlenecks
Let’s work together to advance your medical device commercialization journey. Complete the form to connect with one of our experts today.
1000+
Clinical Trials
20+
Years Focused on Med Device
500+
Regulatory Submissions
94%
Clients Rate Us Higher Than Other CROs
Bringing innovations to market across a range of medical disciplines.
Beaufort’s team of experts have vast experience and backgrounds in a wide spectrum of medical specialties:
What Our Clients Say
Why Beaufort?
Beaufort is a MedTech-focused CRO with deep expertise in accelerating medical device, IVD, and digital health innovations to market. Unlike traditional CROs, we're purpose-built for MedTech companies, combining specialized industry knowledge with agile teams that adapt seamlessly to your unique challenges.
Our customer-centric approach transforms us into a true extension of your team—delivering tailored solutions across regulatory strategy, clinical study design, and market clearance and approval. With Beaufort's solution-oriented philosophy, we navigate obstacles efficiently, minimize risks, and accelerate timelines. The end result is your diagnostic and device innovations reach the market with speed, precision, and confidence that other CROs simply cannot match.
"
Appreciate [Beaufort’s] support and collaboration - we would not be here without all of your diligence and hours dedicated to screening, enrolling, and managing the trial. THANK YOU!
VP, Clinical Operations,
Spectral Medical
"
I am happy to share that late yesterday, our company was granted FDA Marketing Authorization for our product. On behalf of everyone at our company, I would like to extend our gratitude for your support to make this possible.
Project Lead, Virtual Incision
Specialized knowledge and experience working on novel medical technologies
Beaufort drives market success across a broad set of cutting-edge medical device innovations:
- Robotic surgery, surgical tools, systems and accessories
- Artificial intelligence and machine learning (AI/ML)
- Diagnostic imaging and monitoring devices
- Software as a Medical Device (SaMD)
- Digital health monitors and mobile apps
- Implantable devices
- Drug delivery devices
Customized Medical Device Solutions
Our medical device experts provide comprehensive support and tailored solutions that accelerate clinical trials for your unique and novel product concepts — cleared, granted, and approved.
Broad Expertise Across Medical Specialties & Device Technologies
With over 20 years of experience, Beaufort has deep expertise to support your medical device’s unique needs across a broad array of medical fields and technologies.
Expertly designed clinical trials to advance your medical device.
Beaufort provides strategic guidance and clinical trial management for your device from planning to commercialization:
- Study design and protocol development
- Site identification (including central laboratory selection), qualification, and training/management
- Supply chain management & logistics
- Data system implementation
- Patient recruitment & enrollment management
- Trial management & monitoring
- Medical oversight & safety (including pharmacovigilance)
- Data/statistical analysis & clinical study report preparation
Navigate complex regulations with confidence
We partner with you to engage with global agencies, align your product with the latest medical device requirements, and streamline regulatory submissions for faster market approval:
- Regulatory strategy development
- Device classification and conformity assessments
- Regulatory preparation and submission support
- Premarket approval (PMA)
- 510(k)
- De novo
- Investigational device exemption (IDE)
- Humanitarian use device (HUD) and humanitarian device exemption (HDE)
- Establishment listing and registration
- United States (U.S.) Agent support
- Technical files/dossiers /IVDR technical documentation (CE marking)
- Labeling and post-market support
Proven quality systems for compliance & success
We ensure your medical device adheres to regulatory guidelines and industry best practices to support a smooth study and approval process:
- Quality management system (QMS) design and implementation
- Quality system regulation (QSR) / ISO13485:2016 audits
- Gap assessment and remediation
- Inspection readiness
- Orthopedic
- Nephrology
- Dental
- Radiology
- General hospital
- Cardiovascular
- Infectious disease
- Ear, nose and throat
- General and reconstructive surgery
- Women’s health
- Ophthalmology
